Whole Foods in hot water with F.D.A.

The F.D.A.'s letter stated that employees of Whole Foods’ North Atlantic Kitchen failed to handle food under the conditions and controls necessary to minimize the risk for contamination.

AUSTIN, TEXAS — Whole Foods Market, Inc. received a warning letteron June 8 from the Food and Drug Administration following an inspection of the retailer’s food manufacturing facility in Everett, Mass., that found “serious violations” of the agency’s regulations for manufacturing, packaging and preparing food.

The letter stated that employees of Austin-based Whole Foods’ North Atlantic Kitchen failed to handle food under the conditions and controls necessary to minimize the risk for contamination, citing observations of employees failing to properly sanitize equipment and food-contact surfaces, and using a hand-washing sink that lacked hot water before handling ready-to-eat foods. Specific instances in the letter referred to employees preparing items such as ready-to-eat pesto, couscous and mushroom quesadilla in rooms where condensate was observed dripping from the ceiling onto the surface below. Other examples described employees cleaning work surfaces and handling exposed product without washing hands or changing gloves in between tasks, and failing to separate soiled dishes from ready-to-eat products.

Additionally, the F.D.A. said it collected an environmental sample found to contain the presence of non-pathogenic bacteria Listeria welshimeri, which was detected on a food-contact surface.

The F.D.A. said Whole Foods must retrain its employees as a corrective action for most of the observed violations.

“This finding demonstrates that conditions exist in and on your equipment that would support the presence and growth of Listeria monocytogenes and indicates that your cleaning and sanitation practices may not be adequate,” the F.D.A. letter stated. “Your firm should consider improving your environmental monitoring program to verify the adequacy of your cleaning and sanitation operation.”

The violations occurred Feb. 10-18, 2016, and have since been addressed and corrected, according to a statement from Whole Foods.

Ken Meyer, executive vice-president of operations for Whole Foods

“We were honestly surprised,” said Ken Meyer, executive vice-president of operations for Whole Foods Market. “We’ve been in close contact with the F.D.A., opened our doors to inspectors regularly since February and worked with them to address every issue brought to our attention.”

According to the June 8 letter, the agency issued its F.D.A. Form-483 Inspectional Observations to Whole Foods on Feb. 26, and the company returned a written response on March 17, indicating that it takes the observations seriously and is committed to correcting all of the issues.

“Despite this, F.D.A. has serious concerns that our investigators found your firm operating under these conditions,” the letter stated. “Further, your response includes retraining of employees as a corrective action for most of the observed violations, but you failed to mention adequate supervision over your specialized food processing operations and how retraining will ensure sustained compliance.

“We do not consider your response acceptable because you failed to provide documentation for our review, which demonstrates that all your noted corrective actions have been effectively implemented. This documentation may include photographs, invoices, work orders, voluntary destruction records of any affected products, certification of actions performed by contractors, and/or any other useful information that would assist us in evaluating your corrections.”

Whole Foods has been given 15 working days from its receipt of the letter to provide step-by-step documentation of actions taken to correct each violation and prevent recurrence.